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Letter from the Editor: Epidemiology Still Rules

Many a drive-by shooting is successful without anyone getting hit, so Del Monte Fresh Produce got to do a victory dance last week after FDA re-opened the U.S. border to cantaloupes from Asuncion Mita, Guatemala.

In exchange, Del Monte Fresh Produce dropped its lawsuit  against FDA in federal court.  FDA had placed Asuncion Mita cantaloupes, marketed by Del Monte Fresh Produce, on the “import alert” list after powerful  epidemiological evidence linked those cants to a Salmonella Panama outbreak earlier this year. 

This dust-up between Del Monte Fresh Produce and FDA was seen as significant in two camps. The food safety community was and remains outraged at Del Monte’s gutter tactics of smearing the science of epidemiology and those who practice it.  It is rare to see a major American corporation being positively medieval in its approach to public policy, but there you have it.

Watching from the sidelines was the other interested party: the rest of the fresh produce industry. Most of the produce industry subscribes to the “Regulation 101” school that you do not initiate court battles with your regulator.  

Still, many in the industry share Del Monte Fresh Produce’s dislike of “import alerts” that can close the U.S. border without a hearing to a product just by giving “guidance” to agents who work the border.  That’s why Del Monte Fresh Produce has picked up a cheering squad for its tougher approach.

“This is big news, perhaps unprecedented,” wrote Jim Prevor, who writes about the produce industry as the Perishable Pundit. “Though the (press) release is all sugar and light, we can’t help but believe that Del Monte’s legal strategy worked. They brought this issue to a head and got it resolved so they can plant for the winter season. That is not always the way these things turn out.”

Clearly, one of the issues that was not brought to a head by the kissy kiss agreement between Del Monte Fresh Produce and FDA is how epidemiology is the first science of food safety. David Acheson, the former FDA associate commissioner for foods, said the litigation that was briefly underway was looking like “epidemiology is on trial.”

Maybe rather than wait until the next time some food company attorney wants to libel and slander an epidemiologist from one of the states or a federal agency, maybe we should put epidemiology on trial to settle a few things once and for all.

Del Monte Fresh Produce was making much noise over the lack of laboratory testing complete with genetic matches — it wanted all in about an hour — for those Guatemalan melons. 

To the extent that this played out in the press, I was especially interested in the comments by Minnesota epidemiologist Kirk Smith about his trade.  He told the Washington Post that it is rare to have the food item involved in an outbreak available for lab work. 

Smith says in a majority of outbreaks, there is no food to test. And he flatly says laboratory confirmation should never be a requisite to naming the food item that is the vehicle of an outbreak.

In his role speaking for many others in the produce industry, Jim Prevor makes the argument that the work that goes on in the lab with genetic fingerprinting and the like is the “best evidence” and public officials should be allowed to speculate until the best is available.

I don’t think so.  Let’s instead make the best calls in the interest of public health with the best information available.  Let’s not have our public health officials giving their families better warnings than they give the general public. (Soviet Union 101)

I’d even put that a little stronger. When experts like Smith and Oregon’s William E. Keene, whose work Del Monte Fresh Produce had the audacity to question, conduct outbreak investigations, the public has a right to know because it’s going to be rock solid truth.

Put another way, when it comes down to whether public officials like Smith and Keene are to believed or the likes of Del Monte Fresh Produce; it is not even close. Del Monte Fresh Produce might have won a little something, but it lost a lot of credibility in this little skirmish.

And, I am still wondering about that open sewer problem they have down in Asuncion Mita.  Did the FDA get any eyes on the ground before government attorneys made this deal?

 

© Food Safety News
  • Art Davis

    One assumes that with the full legal resources of the United States Government available the FDA took a look at this case (Del Monte melons) and decided they didn’t want to get into the legal battle. I wonder why they made this decision?
    That aside there is no doubt that epidemiology is a very robust approach to determining the source of food born disease. Very robust, not perfect. When statistics / epidemiology add up to 95% confidence that A caused B they are just as certainly accepting the fact that 5% of the time (1 out of 20) they could well be wrong. Rather than make the Del Monte case some sort of be all and end all challenge to epidemiology perhaps it would be more correct to say that Del Monte looked at the evidence in this case and decided it might be wrong or incomplete and, in the end, it appears that the FDA may have agreed. I say may have only because I do not know why FDA made the decision not to contest. It may have been that they thought they would lose, it may have been for other reasons. It would indeed be interesting to know their reasoning.
    In the final analysis I see nothing wrong with Del Monte choosing to contest an FDA decision. FDA is not above error and all regulatory functions should be accountable for their decisions.

  • I urge every reader of this “Letter from the Editor” to stop right now and read what Jim Prevor actually wrote in his article, “FDA Quickly Settles with Del Monte Fresh” http://www.perishablepundit.com/index.php?date=09/27/11#2.
    I just re-read it and don’t find Dan Flynn’s characterization of Prevor’s analysis to be accurate.
    Epidemiology, itself, was never on trial.
    The epidemiological work in this case was questioned and, very importantly to Del Monte Fresh, whether or not it was a sufficient basis for the FDA’s regulatory actions. And, ultimately, Del Monte Fresh asserted that, just as we, food producers, must be held accountable for that which we produce, our regulators must be held accountable for their work.
    Finally, I disagree that “epidemiology is the first science of food safety.” Without the math upon which it is based, epidemiology would be like looking for a steel needle in a haystack without a magnet. It isn’t just a coincidence that the same probability theory is the basis of all quality assurance sampling. And its limitations are what led Dr. Howard Bauman to develop HACCP over 50 years ago.

  • I urge every reader of this “Letter from the Editor” to stop right now and read what Jim Prevor actually wrote in his article, “FDA Quickly Settles with Del Monte Fresh” http://www.perishablepundit.com/index.php?date=09/27/11#2.
    I just re-read it and don’t find Dan Flynn’s characterization of Prevor’s analysis to be accurate.
    Epidemiology, itself, was never on trial.
    The epidemiological work in this case was questioned and, very importantly to Del Monte Fresh, whether or not it was a sufficient basis for the FDA’s regulatory actions. And, ultimately, Del Monte Fresh asserted that, just as we, food producers, must be held accountable for that which we produce, our regulators must be held accountable for their work.
    Finally, I disagree that “epidemiology is the first science of food safety.” Without the math upon which it is based, epidemiology would be like looking for a steel needle in a haystack without a magnet. It isn’t just a coincidence that the same probability theory is the basis of all quality assurance sampling. And its limitations are what led Dr. Howard Bauman to develop HACCP over 50 years ago.